Newsletter – Vol. 2, No. 1

February 1, 2003

The Institute for Sexual Medicine, composed of the Center for Sexual Medicine and Laboratory for Sexual Medicine Research, is dedicated to the diagnosis and treatment of patients with sexual health problems. This is achieved through the pursuit of multidisciplinary basic science and clinical research, training and education of health care professionals, and the promotion of the exchange of scientific information.

Message from our Center Director
Irwin Goldstein, MD

I am happy to hear from so many of you that you enjoy our quarterly newsletter. You may also want to check our website https://www.bumc.bu.edu/sexualmedicine on a regular basis, as our webmaster is constantly updating material. You are also invited at any time to contribute something to the patient testimonials page, although I cannot promise that everything you write will be published on line. You may write the webmaster at ism@bu.edu. Patients and non-patients have been signing on to the patient support groups at http://www.geocities.com/justinpfister/, so be sure to check it out.

I would like to take this opportunity to tell you a little about the unique facility we have in Boston. In addition to treating men and women with sexual medicine problems in the Center for Sexual Medicine, our staff conducts clinical research in order to learn more about how to help our patients. Please read the message from our consultant Linda Frattura to learn more about our clinical research. We also have a unique opportunity to study the mechanisms of sexual function and dysfunction in our basic science research facility, the Laboratory for Sexual Medicine Research.

Message from our Laboratory Director
Abdulmaged Traish, PhD

One of the goals of the Institute for Sexual Medicine at Boston University School of Medicine is to advance basic and clinical research in the field of sexual medicine. To attain this goal, we have embarked on integrated basic and clinical research programs to advance our understanding of the physiology, biochemistry and molecular bases of sexual dysfunction. While advances in investigating male erectile function have led to successful development of FDA approved, safe and effective pharmacologic agents for treatment of erectile dysfunction (MUSE, Caverject, Viagra, etc.), no pharmacologic agents are available for treatment of sexual arousal dysfunction in women.

Sex steroid hormones (e.g. DHEA, testosterone, estradiol, progesterone) play an important role in sexual function. However, their role in female sexual arousal function remains poorly understood. One of the current research projects in our laboratory is aimed at developing new animal models to study how various sex steroid hormones regulate blood flow during sexual arousal in women. Using both physiological, histological and biochemical techniques, we are in the process of characterizing changes in the vagina in the animal model that occur in response to varying hormone levels.

We are also investigating the role of nitric oxide in regulating vaginal blood flow. This is of paramount importance since this may provide potential opportunities for development of specific new therapeutic agents for improving peripheral genital sexual arousal in women. An animal model is being developed to delineate the mechanisms of nitric oxide in vaginal hemodynamics.

As our studies turn progressively towards sexual function in women, we maintain an active research program investigating sexual function in men. While the role of androgens in developmental biology and sexual differentiation is well established, regulation by androgens of erectile function in men remains controversial. In animal models, we have shown that androgens are important for maintaining the elasticity of the erectile tissue in the penis. A lack of androgens leads to changes in erectile tissue structure and erectile dysfunction. Using an interdisciplinary approach, we are studying the role of androgens and how they regulate penile tissue structure, physiology and erectile function. More importantly we are developing tools to investigate the molecular changes underlying the mechanisms by which androgen insufficiency may result In vasculogenic erectile dysfunction. Studies are underway on the role of androgens in erectile function.

Message about Clinical Trials
from our consultant Linda Frattura

Clinical trials or clinical studies are research studies in which people help doctors find ways to improve health and health care. Many of today’s treatments for cancer are based on the results of past clinical trials.

Every research center that takes part in a multicenter trial uses the same protocol. This ensures that information from all centers can be combined.

Clinical trials have several procedures in place to protect the safety of the people who enroll in the study. One procedure is that the study needs to be submitted to and approved by the hospital’s Institutional Review Board (IRB) whose members do not have any personal interest in the results of the study which would bias them.

The doctor/nurse will provide a consent form that goes over key facts about a clinical study, including details about the study approach and tests you may have, and the benefits and risks that could result. You will be asked to sign this form if you decide to take part in the study. Choosing to participate in a clinical trial is an important decision, and you should feel at ease with your decision.

Even if they don’t lead to new therapies, clinical trials often answer important questions and help move research forward. You need to weigh the benefits and risks for yourself. Remember, if you join a clinical trial, you can change your mind at any time.

Clinical trials currently being conducted at the Center for Sexual Medicine are always listed on our website. They are included here so that you may see the kinds of clinical research currently being conducted in our facility.

CURRENT CLINICAL TRIALS FOR WOMEN

Study Title: A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED FIXED DOSE MULTI-CENTER STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERATION OF ORAL SILDENAFIL ADMINISTERED FOR 12 WEEKS TO POST-MENOPAUSAL WOMEN WHO HAVE BEEN DIAGNOSED WITH FEMALE SEXUAL AROUSAL DISORDER
**Women must be either 50 or older whose last menstrual cycle was a minimum of 1 year ago, or under 50 whose last menstrual cycle was a minimum of 2 years ago

Study Title: A RANDOMIZED DOUBLE BLIND DOUBLE DUMMY PLACEBO CONTROLLED FIXED DOSE MULTI-CENTER STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERATION OF ORAL SILDENAFIL ADMINISTERED FOR 12 WEEKS TO PREMENOPAUSAL WOMEN WHO HAVE BEEN DIAGNOSED WITH FEMALE SEXUAL AROUSAL DISORDER
**Women must be 18 years of age or older

If you are interested in finding out more about these investigational studies, please call Paula Kee, RN at 617-414-7022.

CURRENT CLINICAL TRIALS FOR MEN

Study Title: A RANDOMIZED DOUBLE BLIND MULTICENTER PARALLEL GROUP THREE MONTH STUDY TO COMPARE THE TOLERABILITY AND EFFICACY OF FLEXIBLE DOSE VARDENAFIL VERSUS PLACEBO IN MEN WITH DEPRESSION AND ERECTILE DYSFUNCTION, DEPRESSION RELATED IMPROVEMENT WITH VARDENAFIL FOR ERECTILE
RESPONSE (DRIVER)
Patients must be male and 18 years or older with a diagnosis of erectile dysfunction (ED) for more than 6 months who also have a mild to moderate major depressive disorder

If you are interested in finding out more about this investigational study, please call Terry Payton, RN at 617-638-8479.

Depression and Sexual Functioning
Stan Ducharme, PhD

Although circulatory and hormonal issues are important factors in sexual health, emotional issues also play a large role in the quality of sexual functioning. Specifically, depression often contributes to sexual problems and can intensify a dysfunction caused by medical issues.

Depression has long been shown to negatively affect sexual performance. It can reduce sexual drive and blunt sexual interest. Depression can reduce energy levels and make it more difficult to achieve optimal physical and sexual functioning. Becoming sexually aroused is difficult if the individual is feeling depressed. Fully enjoying sex may be impossible under these conditions.

Further complicating the effects of depression is the fact that many of the newer anti-depressants also have profound side effects that can negatively impact sexual abilities. Commonly used anti-depressants such as Prozac, Zoloft, Paxal and others can influence sexual abilities in a number of ways. This family of medications, known also as SSRI’s, can reduce sexual interest, decrease the ability to achieve erections, reduce vaginal lubrication, prohibit male ejaculation and diminish the capacity for orgasm in both men and women.

When fatigue and depression are present, a number of considerations may be worthwhile. Although it may limit spontaneity, enjoy sexual activities when you are well rested and refreshed. Many doctors, in fact, believe that sexual activities in the morning can be more satisfying. Nighttime oxygenation of the genitals and nocturnal erections often mean better sexual functioning earlier in the day. Later in the day, try a short nap before making love. If making love in the evening, try having sex before eating a heavy meal or before drinking alcohol. Maximize the effects of Viagra by taking it on an empty stomach when well rested.

Be realistic about your abilities and communicate these to your partner. Even for men, it’s OK not to be in the mood for sex or to realize that you are too tired at the present time. If you are not in the mood for sex don’t try to fake it. Be sensitive, honest and clear about your needs and desires. Communicating these to your partner can reduce performance anxiety and lessen the chance that your sexual encounter will end in disappointment and frustration.

In summary, sexual dysfunction and depression go hand and hand. There is no reason to feel shame or embarrassment if you find yourself depressed. Such feelings are commonplace in today’s society. Untreated, depression however, can be self-defeating and potentially dangerous. Typically, counseling and medications either alone or in combination with one another are the most common and effective treatments of depression. These treatments can significantly improve appetite and sleep, restore energy and ultimately renew sexual interest.

Information Sessions

Our information sessions have been growing in popularity. For those of you who have not had an opportunity to participate, these are free sessions open to anyone (so bring your father, your sister, your neighbor) held on a monthly basis at the Boston Medical Center. Each session opens with an educational lecture on the topic and is followed by a patient advocate sharing his or her story. Then the floor opens to conversation, from questions to the lecturer or the patients, to sharing of the attendees personal story. Come to one, come to all. Upcoming sessions include: Bike riding and your sex life, February 20, 2003, 7:00 – 9:00 pm: Sexual dysfunction following hysterectomy, March 20, 2003, 7:00 – 9:00 pm; Choosing the right pill to treat your erectile dysfunction, April 17, 2003, 7:00 – 9:00 pm; and Renewing your sex life after childbirth, May 15, 2003, 7:00 – 9:00 pm. There is no pre-registration necessary. For questions please call 617 638-8576. If you are interested in participating as a patient advocate please write ism@bu.edu.

At the request of our patients, we will publish a synopsis of the information sessions so that those people too far to travel may benefit. To protect the privacy of those attending, no names will be used.

In November Terry Payton, RN presented the possible treatments for men suffering from erectile dysfunction following surgery for prostate cancer. Although Viagra works in some patients, a common therapy is intracavernosal injection. Ultimately if these therapies do not work, a penile prosthesis (implant) is recommended. At the Center for Sexual Medicine we have developed some innovative mixtures specifically designed for men who have undergone radical prostatectomy. These new mixes include prostaglandin at varying concentrations. Historically prostaglandin produces some pani/discomfort post injection. We have been able to eliminate the pain factor thus helping many men regain their erectile function and without the necessity of implantation of a prosthesis. The meeting was well attended, and audience members had many questions for both Mr. Payton and the patient presenting his story.

The January meeting was so crowded, Dr. Goldstein and Dr. Munarriz were carrying in extra chairs! Dr. Munarriz addressed the most common sexual dysfunction in women: low interest. He explained about the necessity for women to have androgens for sexual function, and discussed the bloodwork necessary to check for androgen insufficiency and the different forms of androgen treatment. The patient advocate told her story, then answered a myriad of questions. Women told of trying to get help for 25 years and more, and finally finding their way to the Institute for Sexual Medicine, or of starting androgen therapy and getting better slowly.

Donations

Tax deductible gifts may be made to the Institute for Sexual Medicine. Please make check payable to Boston Medical Center/Irwin Goldstein, MD, write ‘ISM donation’ on the memo line and mail to Jerie McGrath, Boston Medical Center, Department of Urology W607, 700 Albany Street, Boston, Massachusetts 02118.